European Biopharmaceutical Review

Spring 2011

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BioBusiness, Finance & Communication

A Watchful Eye

Michael Rosenberg of Health Decisions Inc explains why monitoring is the single most important safeguard for clinical studies and considers the methods available for accurately gauging the trajectory of a trial.

Digital Directions

As the regulatory pressure on small and medium-sized companies increases, electronic document management system software is being tailored to maintain efficiency standards. Keith Williams of GxPi looks at how to implement these hosted systems to enhance functionality.

Blockbuster Takeover

The acquisition of Genzyme grabbed headlines as the largest pharmaceutical company takeover in the industry for years. Daniel Bastide from Thomas Eggar LLP reports on the negotiations that made the purchase possible.

Perfect Partnering

Ross McLennan of TMRI Ltd shows how a multitude of collaborations between industries can allow for stronger adaptive clinical designs, and details some of the initiates already in place that prove what they can offer.

Software Solutions

The burden of the industry’s livelihood is dependent on the success of partnerships. Alison Shurell at IntraLinks explains how embracing new technology can effectively speed up the communication chain.

Scott Preiss, Alberta Di Pasquale, Marleen Mergaerts and Nathalie Garçon at GlaxoSmithKline Biologics discuss vaccines in common use and the factors that go into narrowing down their design goals.

Learning from Experience

Using examples of exogenous virus contamination, Andy Bailey of ViruSure GmbH reviews the vulnerability of the biotech manufacturing process from sources yet to be identified.

Mind the Messenger

Raymond Verhaert and Victor Schut of ProteoNic review the technology affecting translational activity, with specific focus on their application to the study of mammalian and yeast cell culture.

Discovery Technology

Stem Cell Innovation

Vanessa Ott and Blake Anson of Cellular Dynamics International look at how the world of induced pluripotent stem cells has changed since it was discovered that they could be extended to human cells.

Big Ideas on a Small Scale

The successful development of miniaturised, automated, speedy and reliable assays in the future will be heavily dependent on nanotechnology, suggests Mike Fisher at NanoKTN in this portrait of what is available currently.

BioDevelopment and Regulatory

Best Practices

Nathalie A Compagnone of Innovative Concepts in Drug Development examines the role of regulatory agencies in diagnostic testing and biomarker development.

New Horizons

Focusing on the rise of the ‘omics’ field, Gustavo Salem of Agilent Technologies, Inc considers the future of integrated biology and explains how a deeper understanding of cellular processes is set to alter the way we view therapeutics.

BioFormulation and Manufacturing

From Lab to Clinic

When streamlining a business, often one of the strongest ways to ensure you have all the necessary expertise is to outsource. Angela Scott and Susan McKee of Angel Biotechnology evaluate the risks and benefits of biomanufacturing using external contractors.

The Perfect Host

John Liddell and Ian Hodgson of MSD BioManufacturing Network demonstrate that if molecule expression can be achieved in E Coli, then lower costs and a faster speed to market will usually follow.

Sustainable Standards

Yaniv Vardi at Sparta Systems Europe Ltd assesses how crucial the enterprise-wide quality management system is in the pharmaceutical and biotechnology industries.

BioRegional

Dragon’s Den

In a comparison of the biotech industry’s US and Chinese workforces, Erik Lundh of J. Robert Scott draws on recent survey findings to report on top hiring issues and the international effect of the ‘brain drain’.

Convergence is currently playing a large part in the growth of the pharmaceutical market. The need for convergence is due to many factors including the declining economy and high competition within the sector. There are many convergences within this sector to date; these include the convergence of food based products with medical and health products and the convergence of prescription drugs to over the counter (OTC) products. Although convergence is helping the pharmaceutical industry expand and develop, it also poses some challenges; these include the regulatory outlook and counterfeiting.More info >>

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integral part of the trade show calendar of companies specializing in pharma
packaging. Every three years 3,800 exhibitors and 170,000 visitors gather in
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